Dialysis precursor composition

ABSTRACT

A dialysis acid precursor assembly including a dialysis acid precursor composition of dry components including anhydrous glucose, a dry acid, a magnesium chloride 4.5-hydrate (MgCl 2 .4.5H 2 O) and a potassium salt or calcium salt, and a moisture-resistant container with a water vapor transmission rate less than 0.2 g/m 2 /d at 38° C./90% RH, wherein the dialysis acid precursor composition is sealed within the container.

This application is the U.S. national phase of International ApplicationNo. PCT/EP2012/075008 filed 11 Dec. 2012 which designated the U.S. andclaims priority to SE 1151235-7 filed 21 Dec. 2011, and U.S. ProvisionalPatent Application Ser. No. 61/578,250 filed 21 Dec. 2011, the entirecontents of each of which are hereby incorporated by reference.

TECHNICAL FIELD

The present invention concerns a dialysis acid precursor composition foruse during preparation of a dialysis acid concentrate solution and forfurther mixing with water, a sodium containing concentrate, and abicarbonate containing concentrate into a ready-for-use dialysissolution. The present invention further concerns a method of providing adialysis acid concentrate solution for dilution with water, a sodiumcontaining concentrate, and a bicarbonate containing concentrate toproduce a ready-for-use dialysis solution.

Even further, the present invention concerns use of said dialysis acidprecursor composition for preparation of a dialysis acid concentratesolution, for preparing a dialysis solution, an infusion solution, areplacement solution, a rinsing solution or a priming solution.

BACKGROUND

When a person's kidney does not function properly uremia is developed.Dialysis is a well established treatment technique for uremia.Essentially, dialysis artificially replaces the functions of the kidney.There are two distinct types of dialysis; hemodialysis and peritonealdialysis.

Hemodialysis involves withdrawing blood from the body and cleaning it inan extracorporeal blood circuit and then returning the cleansed blood tothe body. The extracorporeal blood circuit includes a dialyzer whichcomprises a semipermeable membrane. The semipermeable membrane has ablood side and a dialysate side. Waste substances and excess fluid isremoved from the blood (passing on the blood side of the semipermeablemembrane) through the semipermeable membrane over to the dialysate sideof the semipermeable membrane.

Hemodialysis may be performed in three different treatment modes;hemodialysis, hemofiltration, and hemodiafiltration. Common to all threetreatment modes is that the patient is connected by a blood line to thedialysis machine, which continuously withdraws blood from the patient.The blood is then brought in contact with the blood side of thesemipermeable membrane within the dialyzer in a flowing manner.

In hemodialysis, an aqueous solution called dialysis solution is broughtin contact with the opposite membrane surface, the dialysate side, in aflowing manner. Waste substances (toxins) and solutes areremoved/controlled mainly by diffusion. Excess fluid is removed byapplying transmembrane pressure over the semipermeable membrane. Solutesand nutrients may diffuse in the opposite direction from the dialysissolution, through the semipermeable membrane and into the blood.

In hemofiltration, no dialysis solution is brought in contact with thedialysate side of the semipermeable membrane. Instead only atransmembrane pressure is applied over the semipermeable membranethereby removing fluid and waste substance from the blood through thesemipermeable membrane wall and into the dialysate side thereof(convective flow). Fluid and waste substances are then passed to drain.To replace some of the removed fluid, a correctly balancedelectrolyte/buffer dialysis solution (also named infusion fluid orreplacement fluid) is infused into the extracorporeal blood circuit.This infusion may be done either pre the dialyzer (pre-infusion mode) orpost the dialyzer (post-infusion mode) or both.

Hemodiafiltration is a combination of hemodialysis and hemofiltration, atreatment mode that combines transport of waste substances and excessfluids through the semipermeable membrane wall by both diffusion andconvection. Thus, here a dialysis solution is brought in contact withthe dialysate side of the semipermeable membrane in a continuouslyflowing manner, and a dialysis solution (also named infusion fluid orreplacement fluid) is used for infusion into the extracorporeal bloodcircuit in pre-infusion mode, post-infusion mode or both.

For many patients, hemodialysis is performed for 3-5 hours, three timesper week. It is usually performed at a dialysis centre, although homedialysis is also possible. When home dialysis is performed the patientis free to perform dialysis more frequently and also in more gentletreatments with longer duration, i.e. 4-8 hours per treatment and 5-7treatments per week. The dose and treatment duration may be adjusted toeach patient's demands and needs.

In the case of patients suffering from acute renal insufficiency, acontinuous treatment, throughout a major portion of the entire day forup to several weeks, a continuous renal replacement therapy (CRRT), orintermittent renal replacement therapy (IRRT) is the indicated treatmentdepending on the patient's status. Also here the removal of wastesubstances and excess fluid from the patient is effected by any or acombination of the treatment modes hemodialysis, hemofiltration andhemodiafiltration.

In a peritoneal dialysis treatment a hypertonic dialysis solution isinfused into the peritoneal cavity of the patient. In this treatmentsolutes and water is exchanged in the capillary vessels of a patient'speritoneal membrane with said hypertonic dialysis solution. Theprinciple of this method is diffusion of solutes transferred accordingto the concentration gradient and water migration due to the osmoticdifferences over the peritoneal membrane.

The dialysis solutions used in all the above dialysis techniques containmainly electrolytes like sodium, magnesium, calcium, potassium, anacid/base buffer system and optionally glucose or a glucose-likecompound. All the components in dialysis solutions are selected tocontrol the levels of electrolytes and the acid-base equilibrium withinthe blood and to remove waste materials from the blood.

Dialysis solutions are today prepared from different types ofconcentrates. It may be liquid concentrates of different degree ofconcentration, where the acid/electrolyte part is separated from thebuffer part. It may be provided in highly concentrated volumes of 1-8 Lin bags for bedside use, or in more diluted concentrated volumes of 5-20L in canisters, which still are for bedside use. Concentrates may alsobe prepared in central tanks in volumes of 300-1000 L.

When using bicarbonate as a buffer component in the dialysis solution,bicarbonate is often provided as a dry concentrate foron-line-preparation of saturated bicarbonate containing concentrate. Thesaturated bicarbonate containing concentrate is thereafter mixed with anacid/electrolyte concentrate and further diluted with purified water toproduce the on-line prepared dialysis solution.

Dialysis solutions have improved in quality over the years, and theavailability of concentrated precursor compositions for further dilutionand mixing with other components into a ready-for-use dialysis solutionhave decreased the costs and improved the environmental issues.

One way to further limit the costs and improve the environmental issueswould be to provide a dialysis precursor composition in which allcomponents are dry. However, having all components as dry componentsadds new problems.

Firstly, dry acid and bicarbonate powder are not compatible. When asmall amount of humidity is present, bicarbonate will break down tocarbon dioxide.

Secondly, magnesium chloride and calcium chloride mixed with bicarbonatewill provide areas were the solubility product of calcium carbonateand/or magnesium carbonate will be exceeded, which would causeprecipitation thereof when water is added during preparation of aconcentrate or a dialysis solution.

Thirdly, even if bicarbonate is excluded to a separate cartridge, stillproblems would be experienced. E.g. caking and lump formation of thedifferent components will render the dissolution thereof more difficultor even impossible when preparing the ready-for-use dialysis solution.

Fourthly, if glucose is present, a discoloration of the precursor, andlater on, the ready-for-use dialysis solution would arise as a result ofglucose degradation products, which should be avoided due to toxicityand limits set by authority regulations, e.g. European Pharmacopeia.

All the problems above are due to the presence of humidity within thedry precursor compositions.

In prior art this has been solved by preparing granulates of thedifferent components and creating different layers of the differentcomponents within each granulate, like disclosed in EP0567452 orEP1714657.

However, this still may give rise to interactions between the differentlayers, and it is also a time-consuming matter of providing a completelyand properly dissolved granulate for the preparation of theready-for-use dialysis solution. Further, it is difficult to ensureproper composition and concentration of the different components bothwithin the granulate and thus also within the finally preparedready-for-use dialysis solution.

SUMMARY OF THE INVENTION

One object of the present invention is to provide a dialysis precursorcomposition which show further improved stability, limited chemicaldegradation and increased shelf life.

Another object of the present invention is to provide a dialysisprecursor composition which give rise to further cost savings andfurther improved environmental benefits.

These objects are achieved, in full or at least in part, by a dialysisacid precursor composition according to claim 1, with differentembodiments defined by dependent claims 2 to 7. These objects are alsoachieved, in full or at least in part, by a method according to claim 8,and a use of the dialysis acid precursor composition according to claims9 and 10.

The present invention concerns a dialysis acid precursor composition foruse during preparation of a dialysis acid concentrate solution and forfurther mixing with water, a sodium containing concentrate, and abicarbonate containing concentrate into a ready-for-use dialysissolution. Said dialysis acid precursor composition consists of powdercomponents comprising glucose, at least one dry acid and at least onemagnesium salt, and optionally potassium salt, and calcium salt.According to the invention said glucose is present as anhydrouscomponent in said dialysis acid precursor composition, and said at leastone magnesium salt is present as magnesium chloride 4.5-hydrate(MgCl₂.4.5H₂O). Further, said dialysis acid precursor composition issealed in a moisture-resistant container with a water vapourtransmission rate less than 0.2 g/m²/d at 38° C./90% RH.

The present invention further concerns a method of providing a dialysisacid concentrate solution for dilution with water, a sodium containingconcentrate, and a bicarbonate containing concentrate to produce aready-for-use dialysis solution. According to the invention this methodcomprises:

(a) providing a dialysis precursor composition comprising glucose, atleast one dry acid, and at least one magnesium salt, optionallypotassium salt, and calcium salt, wherein said glucose is present asanhydrous component in said dialysis acid precursor composition andwherein said at least one magnesium salt is present as magnesiumchloride 4.5-hydrate (MgCl₂·4.5H₂O),

(b) providing said dialysis precursor composition in a sealed,moisture-resistant container with a water vapour transmission rate lessthan 0.2 g/m²/d at 38° C./90% RH, and

(c) adding a prescribed volume of water to said dialysis precursorcomposition in said container and mixing thereof, thereby providing saiddialysis acid concentrate as a solution.

The present invention further concerns use of said dialysis acidprecursor composition for preparing a dialysis acid concentratesolution.

Finally, the present invention concerns use of said dialysis acidprecursor composition for preparing a dialysis solution, an infusionsolution, a replacement solution, a rinsing solution, or a primingsolution.

Other embodiments of the present invention are evident from thedescription below and the dependent claims.

DETAILED DESCRIPTION OF THE INVENTION

A wide variety of different combinations and partitions of dry powdercomponents of normal dialysis solutions like potassium chloride,magnesium chloride, calcium chloride, glucose, sodium chloride, sodiumbicarbonate, dry acids like citric acid, glucono-δ-lactone, etc. wereprepared and put in a forced stability study. Matters like caking, lumpformation, discoloration and dissolution rate were investigated after 1month, 4 months and 10 months storage time.

It was identified that, as expected, sodium bicarbonate needs to beseparated from the other components due to carbon dioxide formation,calcium carbonate precipitation, and magnesium carbonate precipitation.However, when combining the remaining components of a normal dialysissolution, the six crystalline water (hexahydrate) attached to magnesiumchloride caused problems with caking and lump formation within thepowder compositions and discoloration of glucose. By replacing magnesiumchloride hexahydrate with magnesium chloride 4.5-hydrate, free flowingand no discoloration evolved. Thus, in order to make sure that a stablecomposition is provided the container material used for storing thecomposition should be moisture-resistant and not allow passage of anamount equal to or above the amount which equals the difference incrystalline water between hexahydrate and 4.5-hydrate magnesium salt.This is achieved with a container material having a water vapourtransmission rate less than 0.2 g/m²/d at 38° C./90% RH.

In another embodiment said container material has a water vapourtransmission rate less than 0.1 g/m²/d at 38° C./90% RH.

In another embodiment said container material as ha water vapourtransmission rate of more than 0.05 g/m²/d at 38° C./90% RH.

In another embodiment said container material has a water vapourtransmission rate between 0.05-0.2 g/m²/d at 38° C./90% RH.

In even another embodiment said container material has a water vapourtransmission rate between 0.05-0.1 g/m²/d at 38° C./90% RH.

According to the invention said dialysis acid precursor compositionconsists of powder components comprising glucose, at least one dry acidand at least one magnesium salt, and optionally potassium salt, andcalcium salt, wherein said glucose is present as anhydrous component insaid dialysis acid precursor composition and wherein said at least onemagnesium salt is present as magnesium chloride 4.5-hydrate(MgCl₂·4.5H₂O) within the moisture-resistant container.

In other embodiments of the present invention said at least one dry acidis selected from the group comprising lactic acid, citric acid, gluconicacid, glucono-δ-lactone, N-acetyl cystein and α-lipoic acid. Thus, acombination of dry acids may be used within said dialysis acid precursorcomposition, and by providing a combination of different dry acids,other functions and effects, in addition to said acidic function, may beprovided, like for instance antioxidative effects (as with gluconicacid, glucono-δ-lactone, N-acetyl cystein and α-lipoic acid),anticoagulation effects (as with citric acid) and so forth.

In other embodiments, in which calcium salt is present, said calciumsalt in said dialysis acid precursor composition, is at least oneselected from the group comprising calcium chloride dihydrate, calciumchloride monohydrate, anhydrous calcium chloride, calcium gluconate,calcium citrate, calcium lactate, and calcium α-ketoglutarate. Thus,also here a combination of different calcium salts may be used.

In another embodiment, said calcium salt is calcium chloride dihydrate(CaCl₂·2H₂O).

In one embodiment said dialysis precursor composition is provided in aspecific amount and is configured to be mixed with a prescribed volumeof water within said moisture-resistant container to provide a dialysisacid concentrate solution. Thus, said moisture-resistant container isconfigured to receive and dispense solutions up to said prescribedvolume.

In one embodiment said prescribed volume may be within the range of from0.3 to 8 L.

In another embodiment said prescribed volume may be within the range offrom 5-20 L.

In even another embodiment said prescribed volume may be within therange of 300-1000 L.

Further, in one embodiment said dialysis acid concentrate solution isconfigured and provided to be diluted within the range of 1:30 to 1:200with water, a sodium containing concentrate, and a bicarbonatecontaining concentrate.

The present invention further concerns a method of providing a dialysisacid concentrate solution. Said dialysis acid concentrate solution isfurther intended to be mixed with additional water, a sodium containingconcentrate, and a bicarbonate containing concentrate to provide aready-for-use dialysis solution. According to the invention said methodcomprises (a) providing a dialysis precursor composition comprisingglucose, at least one dry acid, and at least one magnesium salt,optionally potassium salt, and calcium salt, wherein said glucose ispresent as anhydrous component in said dialysis acid precursorcomposition and wherein said at least one magnesium salt is present asmagnesium chloride 4.5-hydrate (MgCl₂·4.5H₂O), (b) providing saiddialysis precursor composition in a sealed, moisture-resistant containerwith a water vapour transmission rate less than 0.2 g/m²/d at 38° C./90%RH, and (c) adding a prescribed volume of water to said dialysisprecursor composition in said container and mixing thereof, therebyproviding said dialysis acid concentrate as a solution.

Glucose is provided in such a quantity in said moisture-resistantcontainer that a concentration of 30-400 g/L is provided in the dialysisacid concentrate solution when a prescribed volume of water has enteredinto said moisture-resistant container.

Said dry acid is provided in such a quantity in said moisture-resistantcontainer that a concentration within the range of 60-800 mEq/L H⁺(acid) is provided in the dialysis acid concentrate solution when aprescribed volume of water has entered into said moisture-resistantcontainer.

Further, said at least one magnesium salt is provided in such a quantityin said moisture-resistant container that a concentration within therange of 7,5-150 mM magnesium ions is provided in the dialysis acidconcentrate solution when a prescribed volume of water has entered intosaid moisture-resistant container.

If present, said calcium salt is provided in such a quantity in saidmoisture-resistant container that a concentration within the range of30-500 mM calcium ions is provided in the dialysis acid concentratesolution when a prescribed volume of water has entered into saidmoisture-resistant container.

If present, potassium salt is provided in such a quantity in saidmoisture-resistant container that a concentration within the range of0-800 mM potassium ions is provided in the dialysis acid concentratesolution when a prescribed volume of water has entered into saidmoisture-resistant container.

In one embodiment said dry dialysis acid precursor composition comprisesthe different components in such an amount that, when said dry dialysisacid precursor composition has been dissolved and mixed with water, asodium concentrate, and a bicarbonate concentrate, it provides aready-for-use dialysis solution comprising from about 130-150 mM ofsodium ions, from about 0 to 4 mM of potassium ions, from about 1-2.5 mMof calcium ions, from about 0.25 to 1 mM of magnesium ions, from about 0to 2 g/l glucose from about 85 to 134 mM chloride ions, from about 2 to4 mEq/L acid, and from about 20 to 40 mEq/L bicarbonate ions.

Thus, the present invention provides a prepackaged container with a drydialysis acid precursor composition for use during preparation of adialysis acid concentrate solution and for mixing with water, a sodiumcontaining concentrate, and a bicarbonate containing concentrate into aready-for-use dialysis solution, wherein said dialysis acid precursorcomposition consists of powder components comprising glucose, at leastone dry acid and at least one magnesium salt. Optionally said dialysisacid precursor composition further comprises potassium salts, andcalcium salts. According to the invention said glucose is present asanhydrous component in said dialysis acid precursor composition, said atleast one magnesium salt is present as magnesium chloride 4.5-hydrate(MgCl₂·4.5H₂O) in said dialysis acid precursor composition and saiddialysis acid precursor composition is sealed in a moisture-proofcontainer with a water vapour transmission rate less than 0.2 g/m²/d at38° C./90% RH.

By using magnesium chloride 4.5-hydrate (MgCl₂·4.5H₂O) powder in a drydialysis acid precursor composition, the dry dialysis acid precursorcomposition unexpectedly remain stable, lump free and without glucosedegradation.

EXAMPLES

By way of example, and not limitation, the following examples identify avariety of dialysis acid precursor compositions pursuant to embodimentsof the present invention.

In example 1-4, the tables show the content of a dry acid precursorcomposition for dilution 1:200. The prescribed volume of each dialysisacid concentrate solution (DACS in tables below) is 1 L, and the finalvolume of each ready-for-use dialysis solution (RFUDS in tables below)is 200 L.

Example 1

Amount Conc in Conc in Ingredient (g) DACS (mM) RFUDS (mM) Potassiumchloride 59.64 800 4 Magnesium chloride 17.63 100 0.5 4.5-hydrateCalcium chloride 51.45 350 1.75 dihydrate Citric acid 38.42 200 1Glucose anhydrous 200 1111 5.55

Example 2

Amount Conc in Conc in Ingredient (g) DACS (mM) RFUDS (mM) Magnesiumchloride 17.63 100 0.5 4.5-hydrate Calcium gluconate 150.6 350 1.75Citric acid 38.42 200 1 Glucose anhydrous 200 1111 5.55

Example 3

Amount Conc in Conc in Ingredient (g) DACS (mM) RFUDS (mM) Potassiumchloride 29.82 400 2 Magnesium chloride 17.63 100 0.5 4.5-hydrateCalcium chloride 44.10 300 1.5 dihydrate Glucono-delta-lactone 35.63 2001 Citric acid 30.74 160 0.8 Glucose anhydrous 200 1111 5.55

Example 4

Amount Conc in Conc in Ingredient (g) DACS (mM) RFUDS (mM) Potassiumchloride 59.64 800 4 Magnesium chloride 17.63 100 0.5 4.5-hydrateCalcium chloride 22.22 200 1 anhydrous Citric acid 38.42 200 1 Glucoseanhydrous 200 1111 5.55

Tests

Tests has been performed to study the stability of different dry powdercompositions, both according to embodiments of the present invention aswell as comparisons. Parameters like caking, lumping and discolorationwere evaluated.

Methods

Plastic films, was welded into bags with 1 compartment.

Composition 1

The amount of powder components of potassium chloride, magnesiumchloride 4.5-hydrate, calcium chloride dihydrate, anhydrous glucose, andcitric acid necessary to produce 230 L of dialysis fluid were filledinto the plastic bags, with a water vapour transmission rate of 0.11g/m²/d at 38° C./90% RH. The bags were sealed and incubated in 30° C.,65% RH, and in 40° C., 75% RH, respectively.

Composition 2

The amount of powder components of potassium chloride, magnesiumchloride 4.5-hydrate, anhydrous calcium chloride, anhydrous glucose, andcitric acid necessary to produce 230 L of dialysis fluid were filledinto plastic bags, with a water vapour transmission rate of 0.11 g/m²/dat 38° C./90% RH. The bags were sealed and incubated in 30° C., 65% RH,and in 40° C., 75% RH, respectively.

Comparison Composition 3

The amount of powder components of potassium chloride, anhydrousmagnesium chloride, calcium chloride dihydrate, anhydrous glucose, andcitric acid necessary to produce 230 L of dialysis fluid were filledinto plastic bags, with a water vapour transmission rate of 2.7 g/m²/dat 38° C./90% RH. The bags were sealed and incubated in 30° C., 65% RH,and in 40° C., 75% RH, respectively.

Comparison Composition 4

The amount of powder components of potassium chloride, magnesiumchloride hexahydrate, calcium chloride dihydrate, anhydrous glucose, andcitric acid, necessary to produce 230 L of dialysis fluid were filledinto glass bottles, thus with no water vapour transmission. The bagswere sealed and incubated in 30° C., 65% RH, and in 40° C., 75% RH,respectively.

Comparison Composition 5

The amount of powder components of potassium chloride, anhydrousmagnesium chloride, anhydrous calcium chloride, anhydrous glucose, andcitric acid, necessary to produce 230 L of dialysis fluid were filledinto the plastic bags, with a water vapour transmission rate of 2.7g/m²/d at 38° C./90% RH. The bags were sealed and incubated in 40° C.,75% RH.

Results

Compositions 1 and 2 have proven to stay stable for at least one year,while comparison compositions 3 and 4 failed due to formation of brownlumps after less than 1 month. Comparison composition 5 also failed dueto formation of brown lumps after 1 to 3 months.

While the invention has been described in connection with what ispresently considered to be the most practical embodiments, it is to beunderstood that the invention is not to be limited to the disclosedembodiments, but on the contrary, is intended to cover variousmodifications and equivalents included within the spirit and the scopeof the appended claims.

The invention claimed is:
 1. A dialysis acid precursor composition foruse during preparation of a dialysis acid concentrate solution and formixing with water, a sodium containing concentrate, and a bicarbonatecontaining concentrate into a ready-for-use dialysis solution, whereinsaid dialysis acid precursor composition consist of powder componentscomprising glucose, at least one dry acid and at least one magnesiumsalt, wherein said glucose is present as an anhydrous component in saiddialysis acid precursor composition, wherein said at least one magnesiumsalt is present as magnesium chloride 4.5-hydrate (MgCl₂·4.5H₂O) andwherein said dialysis acid precursor composition is sealed in amoisture-resistant container with a water vapor transmission rate lessthan 0.2 g/m²/d at 38° C./90% RH.
 2. The dialysis precursor compositionaccording to claim 1, wherein said at least one dry acid is selectedfrom a group comprising lactic acid, citric acid, gluconic acid,glucono-δ-lactone, N-acetyl cystein and α-lipoic acid.
 3. The dialysisprecursor composition according to claim 1, wherein said calcium salt insaid dialysis acid precursor composition further includes at least oneof calcium chloride dihydrate, calcium chloride monohydrate, anhydrouscalcium chloride, calcium gluconate, calcium citrate, calcium lactate,and calcium α-ketoglutarate.
 4. The dialysis precursor compositionaccording to claim 1, wherein said powder components include calciumchloride dihydrate (CaCl₂.2H₂O).
 5. The dialysis precursor compositionaccording to claim 1, wherein said moisture-resistant container has awater vapour transmission rate of less than 0.1 g/m²/d at 38° C./90% RH.6. The dialysis precursor composition according claim 1, wherein saidmoisture-resistant container has a water vapour transmission rate ofmore than 0.05 g/m²/d at 38° C./90% RH.
 7. The dialysis precursorcomposition according to claim 1, wherein said dialysis precursorcomposition is configured to be mixed with a prescribed volume of waterwithin said moisture-resistant container to provide a dialysis acidconcentrate solution.
 8. A method of providing a dialysis acidconcentrate solution for dilution with water, a sodium containingconcentrate, and a bicarbonate containing concentrate to produce aready-for-use dialysis solution, comprising: (a) providing a dialysisprecursor composition comprising glucose, at least one dry acid, and atleast one magnesium salt, wherein said glucose is present as anhydrouscomponent in said dialysis acid precursor composition, and wherein saidat least one magnesium salt is present as magnesium chloride 4.5-hydrate(MgCl₂.4.5H₂O), (b) providing said dialysis precursor composition in asealed, moisture-resistant container with a water vapor transmissionrate less than 0.2 g/m²/d at 38° C./90% RH, and (c) adding a prescribedvolume of water to said dialysis precursor composition in said containerand mixing thereof, thereby providing said dialysis acid concentrate asa solution.
 9. A method comprising preparing a dialysis acid concentratesolution using the dialysis acid precursor composition according toclaim
 1. 10. A method comprising preparing a dialysis solution, aninfusion solution, a replacement solution, a rinsing solution or apriming solution using the dialysis acid precursor composition accordingto claim
 1. 11. A dialysis acid precursor assembly comprising: adialysis acid precursor composition consisting of dry componentscomprising anhydrous glucose, a dry acid and a magnesium chloride4.5-hydrate (MgCl₂.4.5H₂O), and a moisture-resistant container with awater vapor transmission rate less than 0.2 g/m²/d at 38° C./90% RH,wherein the dialysis acid precursor composition is sealed within thecontainer.
 12. The dialysis acid precursor of claim 1 wherein the powdercomponents further comprises at least one of a potassium salt and acalcium salt.
 13. The method of claim 8 wherein the dialysis acidprecursor composition further comprises at least one of a potassium saltand a calcium salt.
 14. The dialysis precursor assembly of claim 11wherein the dry components further comprise at least one of a potassiumsalt and calcium salt.